Johnson & Johnson Pharmaceutical Research & Development (J&JPRD)has submitted a New Drug Application (NDA) to the FDA for Tapentadol extended release (ER) tablets.
Tapentadol is an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older. It binds to mu-opioid receptors and inhibits norepinephrine re-uptake.
J&JPRD is conducting the clinical program for Tapentadol in the US. The company submitted the NDA for Tapentadol on behalf of Ortho-McNeil-Janssen Pharmaceuticals, an affiliated company that will hold the NDA for Tapentadol. Upon FDA approval, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, will market Tapentadol in the US.
Nucynta (Tapentadol) CII immediate release tablet formulation is approved by the FDA and is available by prescription only for the relief of moderate to severe acute pain in patients 18 years of age or older. The Tapentadol molecule is classified as schedule II of the Controlled Substances Act.
The company said that the submission is based on a full clinical development program for Tapentadol. The program includes Phase 3 double-blind, randomised, active-and placebo-controlled studies.
These clinical trials explored the efficacy and safety of Tapentadol ER for the treatment of moderate to severe pain in patients with chronic osteoarthritis and low back pain, as well as in patients with diabetic peripheral neuropathic pain. In addition, a one-year, active-control open-label Phase 3 safety trial also was included.
Data from these studies provide evidence that Tapentadol ER has efficacy to reduce moderate to severe chronic pain compared to placebo. The data also provide evidence of long-term safety and tolerability of Tapentadol.
The Tapentadol tablet formulation is designed to provide a high degree of mechanical resistance, such as to crushing or chewing.